Book description
Sets forth the state of the science and technology in plasma
protein production
With contributions from an international team of eighty leading
experts and pioneers in the field, Production of Plasma Proteins
for Therapeutic Use presents a comprehensive overview of the
current state of knowledge about the function, use, and production of
blood plasma proteins. In addition to details of the operational
requirements for the production of plasma derivatives, the book
describes the biology, development, research, manufacture, and
clinical indications of essentially all plasma proteins with
established clinical use or therapeutic potential.
Production of Plasma Proteins for Therapeutic Use covers the
key aspects of the plasma fractionation industry in five sections:
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Section 1: Introduction to Plasma Fractionation
initially describes the history of transfusion and then covers the
emergence of plasma collection and fractionation from its earliest
days to the present time, with the commercial and not-for-profit
sectors developing into a multi-billion dollar industry.
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Section 2: Plasma Proteins for Therapeutic Use
contains 24 chapters dedicated to specific plasma proteins,
including coagulation factors, albumin, immunoglobulin, and a
comprehensive range of other plasma-derived proteins with
therapeutic indications. Each chapter discusses the physiology,
biochemistry, mechanism of action, and manufacture of each plasma
protein including viral safety issues and clinical uses.
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Section 3: Pathogen Safety of Plasma Products
examines issues and procedures for enhancing viral safety and
reducing the risk of transmissible spongiform encephalopathy transmission.
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Section 4: The Pharmaceutical Environment Applied to Plasma
Fractionation details the requirements and activities
associated with plasma collection, quality assurance, compliance
with regulatory requirements, provision of medical affairs
support, and the manufacture of plasma products.
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Section 5: The Market for Plasma Products and the Economics
of Fractionation reviews the commercial environment
and economics of the plasma fractionation industry including
future trends, highlighting regions such as Asia, which have the
potential to exert a major influence on the plasma fractionation
industry in the twenty-first century.
JOSEPH BERTOLINI, BSc (HONS.), MSc, PhD, is R&D
Manager at CSL Bioplasma where he has been closely involved in the
technical development and improvement of immunoglobulin and albumin
products. He is active in national and international conferences and
industry organizations and is a strong advocate for the advancement of bioprocessing.
NEIL GOSS, BSc (HONS.), PhD, is Executive Director at
Further Options Pty Ltd., a consulting company specializing in
biotechnology and the plasma fractionation industry. He was previously
Director of R&D, CSL Bioplasma and is the founding organizer for
both the Plasma Product Biotechnology Meeting series and the
BioProcessing Network.
JOHN CURLING, BSc, is a consultant in bioseparations and
protein purification whose clients have included numerous
biopharmaceutical, biotechnology, and vendor companies. He pioneered
the development of chromatographic methods of plasma fractionation and
was the President of the Process Separation Division of Pharmacia. He
has acted as an advisor to the World Health Organization.
